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FDA 510(k) Application Details - K080931
Device Classification Name
Reagents, Clostridium Difficile Toxin
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510(K) Number
K080931
Device Name
Reagents, Clostridium Difficile Toxin
Applicant
BIOMERIEUX, INC.
595 ANGLUM RD.
HAZELWOOD, MO 63042 US
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Contact
NIKITA S MAPP
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Regulation Number
866.2660
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Classification Product Code
LLH
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More FDA Info for this Product Code
Date Received
04/02/2008
Decision Date
06/11/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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